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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN

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INSULET CORPORATION OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN Back to Search Results
Model Number 14000
Device Problem Deployment issue
Event Date 12/09/2013
Event Type  Malfunction  
Event Description

The customer's mother reported on (b)(6) 2013 her daughter's blood glucose reached 444 mg/dl less than 3 hours after the pod was activated. The pod was deactivated and she noticed the needle did not deploy the cannula all the way into the infusion site. She also stated the pod site was completely wet.

 
Manufacturer Narrative

The product was not returned for evaluation. We are unable to confirm the reported failure of the needle mechanism to fire and deploy the cannula or to determine its root cause. Qualification records were reviewed and the product lot met all acceptance criteria.

 
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Brand NameOMNIPOD INSULIN PUMP
Type of DevicePUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
bedford MA
Manufacturer Contact
michael doyle
9 oak park dr.
bedford , MA 01730
7814575000
MDR Report Key3644811
Report Number3004464228-2014-00022
Device Sequence Number1
Product CodeLZG
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/09/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/07/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device EXPIRATION Date02/01/2015
Device MODEL Number14000
Device Catalogue NumberZXP425
Device LOT NumberL40566
OTHER Device ID Number0000304
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received12/09/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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